Next-generation anti-CD19 CAR-T, Anbal-cel (CRC01), approval highlights Korean innovation

Given the accelerating global momentum in CAR-T and gene therapies, ProBio Inc. and Curocell have achieved a significant milestone with the BLA regulatory approval and commercial readiness of Anbalcabtagene autoleucel (Anbal-cel; code: CRC01). This next-generation CD19-targeted CAR-T cell therapy is developed for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This approval not only highlights Korea's growing innovation in advanced therapies but also marks a critical step towards bringing transformative treatment options to patients. 

Clinical data from Phase 1/2 studies has demonstrated compelling efficacy, with an overall response rate (ORR) of 82% and a complete response (CR) rate of 82% in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The therapy also exhibited a manageable safety profile, with the most commonly reported grade 3/4 adverse events including neutropenia, anemia, and thrombocytopenia. 

A key differentiating feature of CRC01 lies in Curocell's proprietary OVIS™ platform, which suppresses the expression of immune checkpoint receptors PD-1 and TIGIT in CAR-T cells. This innovative mechanism is designed to address immune suppression within the tumor microenvironment, potentially enhancing therapeutic efficacy compared to conventional CAR-T approaches. 

As a strategic partner of Curocell, Probio has supported the journey from post-IND supplier change to BLA application and commercial production. We partnered closely with the client to manage complex change control activities and secure rapid regulatory approval for major process and site changes. With deep expertise in lentiviral vector manufacturing, we completed process characterization within four months, defined critical process parameters, implemented a robust control strategy, and achieved first‑pass success across all three validation batches. Our strong performance during the MFDS pre‑approval inspection, from audit readiness to real‑time responses, was recognized by both regulators and the client. We successfully obtained MFDS GMP certification, representing the first GMP approval for a lentiviral vector manufacturing facility in Korea and reinforcing our role as a pioneer in the local cell and gene therapy supply chain.

The program has now progressed into the commercial manufacturing phase. ProBio remains committed to delivering high-quality plasmid and viral products, supporting the broader adoption of CAR-T therapy, enabling patient access. "We are thrilled to witness this landmark achievement by Curocell," said Allen GUO, CEO from ProBio. "This approval not only represents a major step forward for patients in Korea but also reinforces the global potential of innovative CAR-T therapies. At ProBio, we remain committed to empowering our partners with integrated CDMO solutions to accelerate the development and commercialization of advanced therapies worldwide."

"The approval of Rimqarto is highly meaningful as it represents the commercialization of Korea's first CAR-T therapy," said Kim Gun-soo, CEO of Curocell. "ProBio has played a key role throughout the entire process, from the clinical stage to process development, quality management, regulatory response, and preparation for commercial production, serving as an important partner in supporting the successful approval and laying the foundation for commercialization." He added, "Moving forward, Curocell plans to improve treatment access for patients in Korea based on a stable global supply chain and quality competitiveness, while continuing to expand into global markets and advance the development of next-generation CAR-T therapies."